EP2007456B1 - Embout buccal pour inhalateur - Google Patents

Embout buccal pour inhalateur Download PDF

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Publication number
EP2007456B1
EP2007456B1 EP07727793.7A EP07727793A EP2007456B1 EP 2007456 B1 EP2007456 B1 EP 2007456B1 EP 07727793 A EP07727793 A EP 07727793A EP 2007456 B1 EP2007456 B1 EP 2007456B1
Authority
EP
European Patent Office
Prior art keywords
amino
phenyl
methoxy
hydroxy
yloxy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP07727793.7A
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German (de)
English (en)
Other versions
EP2007456A1 (fr
Inventor
Herbert Wachtel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim Pharma GmbH and Co KG
Original Assignee
Boehringer Ingelheim Pharma GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boehringer Ingelheim Pharma GmbH and Co KG filed Critical Boehringer Ingelheim Pharma GmbH and Co KG
Priority to EP13176790.7A priority Critical patent/EP2656867B1/fr
Publication of EP2007456A1 publication Critical patent/EP2007456A1/fr
Application granted granted Critical
Publication of EP2007456B1 publication Critical patent/EP2007456B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A61M15/0026—Hinged caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/14—Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws

Definitions

  • the invention relates to a mouthpiece for an inhaler for the administration of a medicament in the form of inhalable substances, substance formulations or mixtures, which has an inhalation channel for coupling to a chamber for receiving the medicament, and an inhaler thereto.
  • the EP 0 911 047 A1 discloses an inhaler for inhalation of powdered medicaments from capsules comprising a base with two windows and a plate in which capsule holders and air inlets are located.
  • an inhalation chamber is connected to the plate, on which a provided with two ground needles, is provided against a spring movable head.
  • a mouth tube is connected to an upper part of the inhaler and a lid hinged to the lower part, the plate and the upper part.
  • the describe DE 39 27 170 A1 and DE10126924 an inhaler for the inhalation of powdered, in particular micronized drugs from capsules, in the housing for receiving the capsules a tubular chamber with a bottom air inlet and a mouthpiece merging air outlet at the opposite end of the chamber and a cutter with two movable in the chamber interior cutting the Opening the capsules are arranged near their upper and lower ends.
  • a sieve plate is arranged, which is part of a funnel-shaped connecting piece, which is plugged onto the beginning of the inhalation channel such that the funnel edge engages with the sieve plate in an insert plate which covers the bottom of the mouthpiece forms.
  • the mesh plate is interchangeably fixed in the press fit between the hopper edge of the connector and a stop of the insert plate. This inhaler is so far to inhaled aerosols in the inhalation channel with an associated deposition of the drug can not be excluded.
  • the object is achieved in that at least one component with an aerodynamic cross-section is provided in the inhalation channel.
  • Inhalers are known under the trade names HandiHaler®, Spinhaler®, Rotahaler®, Aerolizer®, Flowcaps®, Turbospin®, AIR DPI®, Orbital®, Directhaler® and / or in DE 33 45 722 .
  • EP 869079 US 3,991,761 . WO 99/45987 . WO 200051672 . Bell, J. Pharm. Sci. 60, 1559 (1971 ); Cox, Brit. Med. J. 2, 634 (1969 ).
  • Powder inhalers are single or multi-dose powder inhalers, in particular the Spinhaler®, Rotahaler®, Aerolizer®, Inhalator®, HandiHaler®, Diskhaler®, Diskus®, Accuhaler®, Aerohaler®, Eclipse®, Turbuhaler®, Turbuhaler®, Easyhaler® , Novolizer®, Clickhaler®, Pulvinal®, Novolizer®, SkyeHaler®, Xcelovair®, Pulvina®, Taifun®, MAGhaler®, Twisthaler® and the Jethaler®.
  • the WO 94/06498 A relates to a medical inhalation device with housing and mouthpiece.
  • This device comprises a drive element which is rotatably mounted in the interior of the device on an axis coaxial with the longitudinal axis of the housing and close to the Air inlet of the device has a receptacle for capsule holder.
  • Rotor blades on the drive member protrude into the air flow passages such that the rotatably mounted drive member is set in rotation and vibration at a generated by inhalation of the patient air flow.
  • the capsule fixedly attached to the drive element is thereby moved and delivers medication through holes, which is carried along by the air flow and inhaled by the patient.
  • the holes are first pricked into the inserted capsule with needles in the device.
  • the WO 02/056948 A shows, for example, a powder inhaler in which a generated by compressed gas in the device gas stream entrains loose powder by hitting or overflowing.
  • the resulting gas-powder dispersion impinges on a baffle before it reaches the mouthpiece.
  • By impinging on the baffle particles are further deagglomerated, and the velocity of the gas stream is slowed down there.
  • Preferred anticholinergic compounds are compounds which are selected from the group consisting of tiotropium salts, preferably the bromide salt, oxitropium salts, preferably the bromide salt, flutropium salts, preferably the bromide salt, Ipratropium salts, preferably the bromide salt, glycopyrronium salts, preferably the bromide salt, trospium salts, preferably the chloride salt, tolterodine.
  • the cations are the pharmacologically active ingredients.
  • the aforementioned salts may preferably contain chloride, bromide, iodide, sulfate, phosphate, methanesulfonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate , Benzoate or p-toluenesulfonate, with chloride, bromide, iodide, sulfate, methanesulfonate or p-toluenesulfonate being preferred as counterions.
  • the chlorides, bromides, iodides and methanesulfonates are particularly preferred.
  • X - is a single negatively charged anion, preferably an anion selected from the group consisting of fluoride, chloride, bromide, iodide, sulfate, phosphate, methanesulfonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate, benzoate and p-toluenesulfonate, preferably a singly negatively charged anion, more preferably an anion selected from the group consisting of fluoride, chloride, bromide, methanesulfonate and p-toluenesulfonate, most preferably bromide, optionally in the form of their racemates, enantiomers or hydrates.
  • anion selected from the group consisting of fluoride, chloride, bromide, iodide, sulfate, phosphate, methanesulfonate, nitrate, maleate, acetate,
  • Preferred dopamine agonists are compounds selected from the group consisting of bromocriptine, cabergoline, alpha-dihydroergocryptine, lisuride, pergolide, pramipexole, roxindole, ropinirole, talipexole, terguride and viozan, optionally in the form of their racemates, enantiomers , Diastereomers and optionally in the form of their pharmacologically acceptable acid addition salts, solvates or hydrates.
  • these acid addition salts are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro-p-toluenesulfonate.
  • Preferred H1 antihistamines are compounds selected from the group consisting of epinastin, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimetinden, clemastine, bamipine, cexchlorpheniramine, pheniramine, doxylamine, chlorphenoxamine , Dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratidine and meclocine, optionally in the form of their racemates, enantiomers, diastereomers and optionally in the form of their pharmacologically acceptable acid addition salts, solvates or hydrates.
  • these acid addition salts are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro-p-toluenesulfonate.
  • inhalable macromolecules can be used as in EP 1 003 478 disclosed.
  • the compound may be derived from the group of derivatives of ergot alkaloids, triptans, CGRP inhibitors, phosphodiesterase V inhibitors, optionally in the form of their racemates, enantiomers or diastereomers, optionally in the form of their pharmacologically acceptable acid addition salts, their solvates and / or or hydrates.
  • medicines come with the o.g. Active ingredients, as well as their salts, esters and the combination of these agents, salts and esters.
  • the component is integrally connected to the inhalation channel and extends radially into the inhalation channel. This saves costs when installing the mouthpiece or inhaler.
  • NACA profile is a symmetric profile of a series of experiments conducted by the National Advisory Committee for Aerodynamic (NACA). NACA profiles are characterized by a rounded nose and a pointed rear part. Different NACA profiles are recordable in Dubs, Fritz, aerodynamics of pure subsonic flow, 4th re-work. Edition, Birkhäuser Verlag Basel, ISBN 3-7643-1073-1, on pages 210 to 213, 218, 219, 222 and 223 described.
  • a NACA profile 0030 or similar profile is used which has been shown to increase the delivered dose of the drug by the use of such a profile over a conventional sieve.
  • the rounded nose of the streamline body in the direction of the mouthpiece and the pointed end to the chamber is used.
  • a plurality of streamline bodies are aligned in a star shape relative to one another.
  • a relatively high stability is ensured, which contributes to the emptying of the vibrating during inhalation capsule.
  • a cyclone-like vortex during inhalation can be produced, which can be used to modify the particle size distribution of the drug, since a strong vortex leads to a preferential deposition of heavy and large particles in the inhalation channel, whereas light active substance particles lead to Patient or user of the inhaler reach.
  • the inhalation channel is preferably round in cross-section.
  • the streamline bodies are expediently arranged on the side of the inhalation channel opposite the mouth side.
  • the mouthpiece together with the inhalation channel and the NACA profiles made of a plastic.
  • the plastics are preferably polymers, thermoplastic polycondensates, polyadducts, modified natural substances or rubbers or mixtures of these plastics. Particularly preferred here are polyolefins, vinyl chloride Pölymerisate, styrene polymers, polyacetals, polyamides, thermoplastic polyesters and polyaryl ethers or mixtures of these plastics.
  • plastics examples include polyethylene, polyvinyl chloride, polyoxymethylene, polyacetal, acrylonitrile / butadiene / styrene (ABS), acrylonitrile / styrene / acrylic ester (ASA), polyamides, polycarbonate, poly (ethylene terephthalate), poly (butylene terephthalate) or poly (phenylene ether ).
  • ABS acrylonitrile / butadiene / styrene
  • ASA acrylonitrile / styrene / acrylic ester
  • polyamides polycarbonate
  • butylene terephthalate poly (butylene terephthalate)
  • phenylene ether poly (phenylene ether ).
  • Such plastics can be obtained, for example, from Ensinger in Germany, Nufringen.
  • the mouthpiece together with the inhalation channel and the NACA profiles arranged therein can be produced by injection molding.
  • the NACA profiles serve as distributors for the plastic melt, it being possible for an injection point to be formed, for example, in the center of the profiles arranged in a star shape relative to each other.
  • a bow-like connection of the webs in the mouthpiece inner channel is possible ( Fig. 2 ).
  • the mouthpiece described above is preferably used in an inhaler for the inhalation of a powdered medicament from a capsule, wherein the inhaler comprises a lower part, on which a lower part latchable plate is hinged to close the lower part.
  • the plate has a capsule holder which can be lowered in the lower part for receiving the capsule and can be locked with the mouthpiece.
  • a lid which covers the mouthpiece in a closed position, is milled by means of a closure element.
  • the lower part, the plate, the mouthpiece and the lid are pivotally connected to each other by a single joint.
  • an actuating member is provided, which is displaceable from a rest position into a movement and with at least one injectable into the capsule holder needle cooperates.
  • two spaced apart needles are provided.
  • the inhaler has a lower part 1, on which a latchable with the lower part 1 plate 2 is hinged for closing the lower part 1.
  • the plate 2 is provided with a retractable in the lower part 1 capsule holder 3 for receiving a filled with a powdered drug capsule in a chamber and with a inhalation channel 4 having mouthpiece 5 locked.
  • a lid 6, which covers the mouthpiece 5 in a closed position, is locked by means of a closure element.
  • the lower part 1, the plate 2, the mouthpiece 5 and the lid 6 are pivotally connected to each other by a common joint 7.
  • an actuator 8 is provided which cooperates with two injectable into the capsule holder 3 needles 9 for piercing the capsule.
  • the spaced apart needles 9 are slidably mounted in guide sleeve 14 of the capsule holder 3. To a return movement of the needles 9 to release the holes in the capsule after releasing the actuator 8 to cause a compression spring 15 is disposed between the capsule holder 3 and the actuator 8.
  • the mouthpiece 5, with the inhalation channel 4, which is round in cross-section, is made of a plastic and is produced by injection molding.
  • a plurality of star-shaped aligned components 10 are arranged with an aerodynamic cross-section.
  • the components 10 are designed as NACA profiles 11 and each have a rounded nose 12 and a pointed end 13, wherein the end may also be rounded in order to simplify the production.
  • the mouthpiece also has one or more webs 16, which prevent the improper introduction of inappropriate capsules, further favorably influence the flow behavior of the inhaler and the exit velocity of the drug.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (9)

  1. Inhalateur pour l'administration d'un médicament sous forme pulvérulente sous la forme de substances pouvant être inhalées, de formulations ou de mélanges de substances d'une capsule, dans lequel l'inhalateur présente un embout buccal (5) qui présente un canal d'inhalation (4) pour le couplage avec une chambre pour la réception de la capsule avec le médicament, caractérisé en ce que dans le canal d'inhalation (4) au moins un élément (10) comportant une section aérodynamique est prévu, dans lequel ledit élément (10) est conçu comme un profil aérodynamique, et en ce que l'élément (10) est relié d'un seul tenant avec le canal d'inhalation (4) et s'étend radialement dans le canal d'inhalation (4).
  2. Inhalateur selon la revendication 1, caractérisé en ce que le nez arrondi (12) du profil aérodynamique est tourné en direction de l'embout buccal (5) et une extrémité pointue (13) est tournée vers la chambre.
  3. Inhalateur selon l'une des revendications précédentes, caractérisé en ce que plusieurs profils aérodynamiques sont orientés les uns par rapport aux autres en forme d'étoile.
  4. Inhalateur selon l'une des revendications précédentes, caractérisé en ce que le profil aérodynamique est disposé sur le côté opposé au côté buccal du canal d'inhalation (4).
  5. Inhalateur selon l'une des revendications 1 à 4, caractérisé en ce qu'il est constitué d'une matière plastique.
  6. Inhalateur selon l'une des revendications 1 à 5, caractérisé en ce qu'il peut être fabriqué dans un procédé de coulage par injection.
  7. Inhalateur selon les revendications 4, 5 et 6, caractérisé en ce qu'un canal d'inhalation (4) de section arrondie est formé dans l'embout buccal et l'embout buccal présente au moins une traverse (16) et cette traverse (16) se trouve sur la paroi intérieure du canal d'inhalation (4).
  8. Inhalateur selon l'une des revendications 1 à 7 pour l'inhalation d'un médicament pulvérulent d'une capsule comportant
    - une partie inférieure (1)
    - une plaque (2) pouvant être encliquetée avec la partie inférieure (1) pour la fermeture de la partie inférieure (1), avec laquelle l'embout buccal (5) peut être encliqueté, et un support de capsule (3) escamotable dans la partie inférieure (1) pour la réception de la capsule,
    - un couvercle (6) qui recouvre l'embout buccal (5) dans une position de fermeture et s'encliquette au moyen d'un élément de fermeture, dans lequel la partie inférieure (1), la plaque (2), l'embout buccal (5) et le couvercle (6) sont reliés les uns aux autres par une articulation (7) unique pouvant basculer, et
    - un organe d'actionnement (8) qui peut être déplacé d'une position de repos à un mouvement et coopère ainsi avec au moins une aiguille (9) pouvant être introduite dans le support de capsule (3).
  9. Inhalateur selon l'une des revendications 1 à 8, pour l'application d'un médicament sous forme pulvérulente ayant un principe actif du groupe des anticholinergiques, des bêta-mimétiques, des stéroïdes, des inhibiteurs de la phosphodiestérase IV, des antagonistes de LTD4, des inhibiteurs de l'EGFR-kinase, des anti-allergiques, des dérivés d'alcaloïdes de l'ergot, de triptans, d'antagonistes de CGRP, d'inhibiteurs de la phosphodiestérase V ainsi que des combinaisons de ces principes actifs.
EP07727793.7A 2006-04-11 2007-04-04 Embout buccal pour inhalateur Active EP2007456B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP13176790.7A EP2656867B1 (fr) 2006-04-11 2007-04-04 Embouchure pour un inhalateur

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006016901A DE102006016901A1 (de) 2006-04-11 2006-04-11 Mundstück für einen Inhalator
PCT/EP2007/053324 WO2007118800A1 (fr) 2006-04-11 2007-04-04 Embout buccal pour inhalateur

Related Child Applications (2)

Application Number Title Priority Date Filing Date
EP13176790.7A Division EP2656867B1 (fr) 2006-04-11 2007-04-04 Embouchure pour un inhalateur
EP13176790.7A Division-Into EP2656867B1 (fr) 2006-04-11 2007-04-04 Embouchure pour un inhalateur

Publications (2)

Publication Number Publication Date
EP2007456A1 EP2007456A1 (fr) 2008-12-31
EP2007456B1 true EP2007456B1 (fr) 2018-10-17

Family

ID=38179783

Family Applications (2)

Application Number Title Priority Date Filing Date
EP13176790.7A Active EP2656867B1 (fr) 2006-04-11 2007-04-04 Embouchure pour un inhalateur
EP07727793.7A Active EP2007456B1 (fr) 2006-04-11 2007-04-04 Embout buccal pour inhalateur

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP13176790.7A Active EP2656867B1 (fr) 2006-04-11 2007-04-04 Embouchure pour un inhalateur

Country Status (8)

Country Link
US (1) US8281784B2 (fr)
EP (2) EP2656867B1 (fr)
JP (1) JP5233049B2 (fr)
CA (2) CA2852845A1 (fr)
DE (1) DE102006016901A1 (fr)
ES (1) ES2734501T3 (fr)
TR (1) TR201910393T4 (fr)
WO (1) WO2007118800A1 (fr)

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Also Published As

Publication number Publication date
EP2007456A1 (fr) 2008-12-31
CA2647951A1 (fr) 2007-10-25
US20100059050A1 (en) 2010-03-11
JP2009533112A (ja) 2009-09-17
EP2656867A2 (fr) 2013-10-30
WO2007118800A1 (fr) 2007-10-25
ES2734501T3 (es) 2019-12-10
JP5233049B2 (ja) 2013-07-10
EP2656867B1 (fr) 2019-05-15
EP2656867A3 (fr) 2014-01-22
US8281784B2 (en) 2012-10-09
CA2647951C (fr) 2015-03-17
DE102006016901A1 (de) 2007-10-25
CA2852845A1 (fr) 2007-10-25
TR201910393T4 (tr) 2019-08-21

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